The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients with newly diagnosed peripheral T-cell lymphoma.
The purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests, etc., of a range of doses of chidamide combined with CHOP in peripheral T-cell lymphoma patients, and to determine the dose limit toxicity and the maximum tolerable dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8 and 11 of each cycle.
On Day 1, cyclophosphamide is given in a 20-minute intravenous (IV) infusion at 750 mg/m\^2 in 5 minutes after chidamide administration
On Day 1, Adriacin is given in a 20-minute IV infusion at 50 mg/m\^2 soon after cyclophosphamide administration.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
dose-limiting toxicity (DLT)
Time frame: Day 1 - 21
Adverse events
Time frame: About 21 weeks
complete response rate
Time frame: About 21 weeks
Duration of response
Time frame: About 21 weeks
Progression free survival
Time frame: About 21 weeks
Objective response rate
Time frame: About 21 weeks
Overall survival
Time frame: About 21 weeks
Area under the concentration versus time curve (AUC)
Time frame: Day 1 of the lead-in period and Day 1 of the combination therapy
Peak plasma concentration (Cmax)
Time frame: Day 1 of the lead-in period and Day 1 of the combination therapy
Time of Cmax (Tmax)
Time frame: Day 1 of the lead-in period and Day 1 of the combination therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
On Day 1, vincristine is given in IV infusion at 1.4 mg/m\^2 after adriacin administration.
On Day 1 to 5, prednisone is given orally at 100 mg once a day